Comments on: The California Pedigree Law http://www.rxtrace.com/2009/09/california-pedigree-law.html/ A comprehensive exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance Fri, 03 Feb 2012 14:02:28 +0000 hourly 1 http://wordpress.org/?v=3.3.1 By: Adam J. Fein, Ph.D. http://www.rxtrace.com/2009/09/california-pedigree-law.html/comment-page-1/#comment-6 Adam J. Fein, Ph.D. Tue, 08 Sep 2009 02:24:18 +0000 http://rxtrace.com/?p=12#comment-6 Fair enough, but as one of my professors used to say:<br /><br />In theory, theory and practice are the same.<br /><br />In practice, they are different.<br /><br />Adam Fair enough, but as one of my professors used to say:

In theory, theory and practice are the same.

In practice, they are different.

Adam

]]> By: Dirk Rodgers http://www.rxtrace.com/2009/09/california-pedigree-law.html/comment-page-1/#comment-5 Dirk Rodgers Tue, 08 Sep 2009 01:48:38 +0000 http://rxtrace.com/?p=12#comment-5 Adam,<br />My comments are focused on the technology and some of the tech-related requirements, not on the funding or the BoP's preparation for enforcement. But the last point I was trying to make in my post was that the type of law they have enacted has the unique ability to automate and distribute the monitoring of the supply chain, and thus should result in lower operational costs than other, less secure approaches, whenever they finally implement.<br /><br />I couldn't agree more with your call for national standards. In my opinion, the California technical approach offers a pretty compeling model as an example. I'll explain more in future posts. Adam,
My comments are focused on the technology and some of the tech-related requirements, not on the funding or the BoP's preparation for enforcement. But the last point I was trying to make in my post was that the type of law they have enacted has the unique ability to automate and distribute the monitoring of the supply chain, and thus should result in lower operational costs than other, less secure approaches, whenever they finally implement.

I couldn't agree more with your call for national standards. In my opinion, the California technical approach offers a pretty compeling model as an example. I'll explain more in future posts.

]]> By: Adam J. Fein, Ph.D. http://www.rxtrace.com/2009/09/california-pedigree-law.html/comment-page-1/#comment-4 Adam J. Fein, Ph.D. Mon, 07 Sep 2009 22:25:15 +0000 http://rxtrace.com/?p=12#comment-4 Hi Dirk,<br /><br />The CA law may be better in some theoretical ways than Florida, but the CA Board of Pharmacy was understaffed, underfunded, and underqualified to implement the law in either '09 or '11. I pointed out some of these shortcomings during the 2008 debate (such as <a href="http://www.drugchannels.net/2008/03/ca-e-pedigree-underground-regulation.html" rel="nofollow">here</a> and <a href="http://www.drugchannels.net/2008/01/pedigree-and-obscenity.html" rel="nofollow">here</a>).<br /><br />Perhaps the Board will be ready by 2015, but believing that would be the triumph of hope over experience. Alas, California's budget crisis makes me skeptical that they will do it right next time. Time to end amateur hour and establish national standards.<br /><br />Just my $0.02.<br /><br />Adam Hi Dirk,

The CA law may be better in some theoretical ways than Florida, but the CA Board of Pharmacy was understaffed, underfunded, and underqualified to implement the law in either '09 or '11. I pointed out some of these shortcomings during the 2008 debate (such as here and here).

Perhaps the Board will be ready by 2015, but believing that would be the triumph of hope over experience. Alas, California's budget crisis makes me skeptical that they will do it right next time. Time to end amateur hour and establish national standards.

Just my $0.02.

Adam

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